Market access of Chinese patent medicine products to healthcare security system in China: implications for international integration of traditional medicine into health systems

Background China has introduced a series of polices and practice to manage the market access of Chinese patent medicine (CPM) products into its healthcare security system, which is less analyzed and reported in current literature. Therefore, this paper aimed to investigate the mechanisms managing market access of CPM products into healthcare security system in China, expecting to provide implications for international integration of traditional medicine products into health systems. Method This paper used a documentary analysis approach as a qualitative research method. Data were collected from four sources and analyzed in a thematic way. Results Four mechanisms to manage entry, price adjustment, and exit of innovative brand and generic CPM products are identified, including: (1) price negotiation, mechanism of new entry of innovative brand CPM products into the national reimbursement list; (2) price re-negotiation, mechanism of price adjustment of innovative brand CPM products within the national reimbursement list; (3) mass procurement, mechanism of generic CPM products to healthcare security system; and (4) direct removal, mechanism of removal from the national reimbursement list. Conclusions China has established market access framework of CPM products by focusing on price negotiation for innovative brand CPM products and mass procurement for generic CPM products. Further studies of CPM products based real-world data are needed to provide clinical and pharmacoeconomic evidence to support market access of CPM products into healthcare security systems.

Access to medicines in Turkey: Evaluation of the process of medicines brought from abroad

ObjectiveTurkey's health reforms started in 2003 with providing changes in regulatory, financing, and healthcare services. Access to health care and pharmaceuticals increased rapidly, and this resulted with an increase in public pharmaceutical expenditures. Our study aims to quantify and to evaluate the impact of a specific process within the Turkish system called “Medicines Brought From Abroad" (MBFA).MethodsWe reviewed the general reimbursement legislations of Social Security Institution (SSI), the guideline on MBFA, the SSI reimbursement list, the list of MBFA published by the Ministry of Health to describe the current supply mechanism of medicines and, in particular, the role of MBFA.ResultsTotal costs of the of MBFA medicines over the period 2011–17 went up to more than $520 million, which takes 7.5 percent of total public pharmaceutical expenditure for 2017. Our results showed that MBFA provides access to many orphan drugs and in total, forty-two orphan drugs listed in MBFA accounted for 83 percent of all MBFA budget in the year 2017. Nine of the top ten MBFA medicines were orphan drugs and total costs were $408 million. The highest budget impact was for eculizumab for “paroxysmal nocturnal hemoglobinuria” (PNH), covering 31 percent of total MBFA costs and 2.3 percent of overall drug costs in 2017.ConclusionsTurkey faced significant challenges for creating an access pathway for innovative medicines while continuing the sustainability of the public pharmaceutical budget like many other countries. Therefore, it may be argued that Turkey needs to create an independent health technology assessment organization to provide sustainable access to medicines in the future.

Biosimilars in the French and Polish System: Chosen Aspects of Reimbursement and Access

The EU approved the first biosimilar drug in 2006. By 2017, the EU had authorized the highest number of biosimilars worldwide, acquiring considerable experience in their use and safety. In May 2019, the European Medicines Agency (EMA) search engine showed 54 authorized biosimilars. Biosimilars reduce public expenditure; however, the discussion about their potential disadvantages is still ongoing. Each country adopts different regulations on the interchangeability, switching, and substitution of a reference medicine by its biosimilar, since the EMA does not regulate this issue. Additionally, each nation has a unique reimbursement system, which results in significant differences in patients’ access to biosimilars. The importance of securing a higher availability of these cheaper versions of biological drugs is well-recognized. The better the access to these biosimilars is, the lower the overall drug expenditure and need for rationing would be, and therefore the better treatment results. The aim of this paper is to compare selected aspects of reimbursement and access to the EMA authorized biosimilar medicines in two countries – France and Poland. The stated drug policy goal of both countries is to significantly improve biosimilar implementation in the coming years. The research is based on an analysis of four main sources: the EMA biosimilars database, the Polish reimbursement list published by the Polish Ministry of Health, and two French reimbursement databases published by the French Ministry of Health. An additional literature review was conducted. The expected results concentrate on differences in the number of reimbursed biosimilars, the average time between EMA authorization and country reimbursement decision date, and the availability of biosimilars registered outside of the centralized (EMA) procedure. These findings could identify areas of improvement and help with discussions on how to optimize the reach of biosimilars, as well as improve French-Polish collaboration on this matter.

Healthcare quality and medicine reimbursement criteria in Iran

Purpose This study aims to measure the quality of services provided to elderly people at the most crowded governmental ambulatory clinics of Tehran Province using the SERVQUAL scale (Study 1). Moreover, the research indicates the medicine reimbursement criteria to inform the decision-makers of public health insurance organizations using the Borda method (Study 2). Design/methodology/approach This study was done as a cross-sectional research on 425 elderly patients who came to the clinics during 2014 and 2015. Finally, using the paired t-test, Friedman test, Borda method, SPSS, Matlab software and Delphi method, the collected data were analysed. Findings Regarding the perceived quality, the services assurance dimension was ranked as having the highest quality (4.48) and the accessibility dimension as the lowest one (3.22). Based on the Borda method, the most important criterion for the Iranian health insurance companies to accept a medicine in their reimbursement list is the “life-threatening conditions” factor. On the other hand, “evidence quality” is accounted as the fifth important factor. Research limitations/implications The main limitation was the senility of participants that makes it difficult for understanding and completing the questionnaires. Practical implications The results can be useful for healthcare policy makers and related authorities. Besides, public health insurers can use the findings for decision-making about the elderly diseases and the problems such as the medical expenses. Originality/value The present research has been done in a two-year time frame, and it is more recent than other related studies. Thus, the results are far more authentic and applicable.